Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Gastric Carcinoma.GOETH Study

Launched by MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH · Apr 15, 2019

Keywords

ClinConnect Summary

The GOETH study is a clinical trial that is looking at two different approaches for treating patients with stomach cancer, also known as gastric carcinoma. In this study, some patients will receive a combination of preventive surgery and a special treatment called HIPEC CO2, which involves delivering chemotherapy directly into the abdomen after surgery. Others will receive standard surgery without the extra treatment. The goal is to see if the combination treatment helps improve outcomes for patients compared to standard surgery alone.

To be eligible for this study, patients need to be between 18 and 75 years old and have a specific type of gastric cancer that can be completely removed through surgery. They should not have certain conditions, like cancer that has spread to other parts of the body or serious health issues that could complicate treatment. Participants can expect to undergo surgery, and, depending on which group they are in, they may receive the additional HIPEC treatment or just standard care. This study is actively recruiting patients and aims to gather important information that could help improve treatment for stomach cancer in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with histologically documented gastric carcinoma (diffuse/intestinal histotype) eligibile for R0.
• • 1. Presurgical or intraoperative stage T3-T4 N0-N+ primary tumour (TNM 8 th).
• • 2. Urgent presentation: perforation without purulent generalized peritonitis
• • 3. Positive cytology of peritoneal fluid (if previously obtained)
• • 2. Age ≥ 18 years and ≤75 years.
• • 3. Written informed consent.
• Exclusion Criteria:
• • 1. Gastroesophageal Junction (GEJ) cancer
• • 2. Distant metastatic disease (even if limited and completely resected)
• • 3. Peritoneal carcinomatosis
• • 4. History of tumor diagnosed in the 3 years before entering the study, except for topical and healed pathologies that do not need further treatment (e.g. non-melanoma skin carcinomas, superficial bladder carcinomas or in situ carcinoma of the breast or cervix).
• • 5. Psychological, family or social conditions which may negatively affect the treatment and follow-up protocol.
• • 6. Poor general conditions (ECOG \> 2).
• • 7. Impaired cardiac function (history of congestive heart failure or FE \<40%). Clinically significant cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrolment), unstable angina, congestive heart failure (New York Heart Association Classification Class \> II) or serious uncontrolled cardiac Arrhythmia requiring medication
• • 8. Impaired renal function (creatinine\> 1.5 upper limit of normal or creatinine clearance \<60 mL / min).
• • 9. Impaired hepatic function (AST, ALT \>2.5 upper limit of normal, bilirubin \> 1.5 upper limit of normal).
• • 10. Impaired hematopoietic function (leucocytes \<4000 / mm3, neutrophils \<1500 / mm 3, platelets \<100000 / mm3).
• • 11. Impaired pulmonary function (presence of COPD or other pulmonary restrictive conditions with FEV1 \<50% or DLCO \<40% of normal age value).
• • 12. History or presence of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of HIPEC or chemotherapy or patient at high risk from treatment complications.
• • 13. Pregnancy.
• • 14. Krukenberg tumor
• • 15. Refusal to join the study.